510(k) K101835

MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079 by Porex Surgical, Inc. — Product Code HBW

K101835 is an FDA 510(k) premarket notification submitted by Porex Surgical, Inc. for the device "MEDPOR FIXATION SYSTEM-CRANIAL, MODELS 80080, 80079". The FDA issued a decision of Substantially Equivalent on December 3, 2010. The device falls under product code HBW (Fastener, Plate, Cranioplasty), a Class II device regulated under 21 CFR 882.5360. Porex Surgical, Inc. has at least 10 other 510(k) clearances on record.